Ethical Dilemma with Stakeholders

Hour-by-Hour Action Plan: 48-Hour Crisis Response

Hours 1-2: Immediate Crisis Assembly & Assessment

Action: convene emergency crisis team (legal, medical, regulatory, communications, senior leadership) Reasoning: Establish unified command structure before information spreads. The medical team needs to validate the findings immediately while legal assesses exposure. This prevents contradictory messaging that could compound the crisis.

Hours 3-4: Internal Investigation & Data Verification

Action: Have pharmacovigilance team conduct immediate review of all adverse event reports, confirm statistical significance, and identify affected patient timeline Reasoning: We must verify the data quality before any public statement. The 1-in-8,000 risk rate needs precise quantification across patient populations and timeframes to inform both regulatory and public communications.

Hours 5-8: Legal & Regulatory Strategy Development

Action: Legal team contacts FDA/EMA immediately to discuss expedited reporting pathways, initiates internal risk assessment with external counsel, begins preparing regulatory submission Reasoning: While the legal team estimates 6 months for formal reporting, there may be emergency exemptions or expedited processes available. Early engagement with regulators builds credibility if we choose to disclose later.

Hours 9-12: Patient Safety Protocol Implementation

Action: Implement internal monitoring systems for at-risk patients, draft physician communication protocols, begin developing patient warning materials Reasoning: Patient safety is paramount. Even if we delay public disclosure, we must ensure healthcare providers know how to monitor patients and that at-risk individuals receive appropriate care.

Hours 13-16: Board Communication & Decision Framework

Action: Prepare comprehensive board presentation including risk/benefit analysis, potential scenarios, financial impact modeling, and timeline recommendations Reasoning: The board must understand the full scope. We need to present three clear options (disclose now, wait 6 months, wait 12 months) with detailed implications for all stakeholders.

Hours 17-20: Stakeholder Engagement & Risk Mitigation

Action: Contact major institutional investors to explain situation, prepare internal memo to employees explaining company's commitment to patient safety, draft crisis communication framework Reasoning: Transparency with key investors helps manage expectations and reduces panic selling. Employee morale is critical - they need clear guidance about their role in potential disclosures.

Hours 21-24: Strategic Decision Finalization

Action: Based on board decision, implement chosen path (if immediate disclosure, prepare regulatory filing and media statement; if delayed, establish monitoring protocols and communication timeline) Reasoning: This is where decisions crystallize. If we choose delay, we must document our rationale clearly for regulatory compliance and future protection.

Hours 25-48: Execution & Ongoing Management

Action: If disclosure chosen: file with regulators within 24 hours of board decision; launch coordinated PR campaign; establish patient support program; if delay chosen: maintain heightened vigilance with quarterly update schedule Reasoning: Clear execution timeline ensures we don't drift from our strategy. The 48-hour window means we must be decisive and act within 12 hours of board meeting resolution.

Critical Decisions & Rationale:

Regulatory Approach:

• DO NOT wait for more data - The 1-in-8,000 rate is significant enough to trigger regulatory requirements. Waiting for additional cases could create worse consequences.
• Engage early with regulators - Even if not formally reporting yet, initial contact establishes good faith cooperation.

Ethical Framework:

• Patient safety first - The ethical obligation to warn patients and physicians outweighs potential financial harm.
• Transparency approach - Full disclosure, even partially, is better than potential litigation from incomplete information.

Financial Impact Management:

• Prepare for market volatility - The 40% drop may be inevitable but we can control how much of it is due to perception vs. facts.
• Consider insurance coverage - Review liability policies for coverage of regulatory actions.

Communication Strategy:

• Consistent messaging - All communications must align with medical facts, legal position, and patient safety.
• Proactive physician outreach - Healthcare providers deserve advance notice to adjust treatment protocols.

This approach balances legal obligations (regulatory reporting requirements), ethical responsibilities (patient safety), and business considerations (minimizing damage). The key is that we make a decision within 48 hours rather than continuing to debate, as indecision itself creates greater risk.